Status:
COMPLETED
Ramipril in Rheumatoid Arthritis
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Sanofi
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
The present study is designed to evaluate the hypothesis that the Angiotensin-Converting Enzyme (ACE) inhibitor Ramipril improves vascular function and reduces markers of low-grade chronic inflammatio...
Detailed Description
The effect of an 8-week treatment with either ramipril or placebo is studied using a randomized, double-blind, and crossover protocol. After given written informed consent, baseline characteristics in...
Eligibility Criteria
Inclusion
- patients with rheumatoid arthritis (4 out of 7 ARA criteria must be fulfilled to establish diagnosis) on stable background therapy for the last three months
- endothelial dysfunction (FMD \< 4%, FMD:Flow-Mediated-Dilatation)
- non-smokers
Exclusion
- previous myocardial infarction, coronary intervention or coronary surgery
- previous treatment with statins in the last 6 months
- previous treatment with ACE-inhibitors in the last 6 months
- uncontrolled hypertension SAP/DAP \> 160/90 mmHg (SAP:Systolic Arterial Pressure, DAP:Diastolic Arterial Pressure)
- dyslipidemia (LDL-cholesterol \> 4.9 mmol)
- normal CRP \< 3 mg/l
- overweight BMI \> 35kg/m2
- anaemia (hemoglobin \< 10g/dl)
- kidney disease (creatinine \> 150 umol/l)
- insulin-dependent diabetes mellitus
- congestive heart failure (\> NYHA I)
- AV-Block\>I
- pregnancy
- angio-edema
- malignancy or chronic infection
- drug abuse
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00273533
Start Date
June 1 2004
End Date
July 1 2006
Last Update
July 22 2008
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